CAMBRIDGE, Mass. - Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company focused on developing treatments for hematologic malignancies, disclosed today that its Phase 3 SELECT-MDS-1 trial did not achieve its primary endpoint. The study tested tamibarotene combined with azacitidine in patients with higher-risk myelodysplastic syndrome (HR-MDS) exhibiting RARA gene overexpression.
The trial's primary measure, the complete response (CR) rate, showed a 23.8% CR in the tamibarotene/azacitidine group versus an 18.8% CR in the placebo/azacitidine group among the first 190 patients. This difference was not statistically significant, with a p-value of 0.2084. Despite the outcome, the treatment was generally well-tolerated, aligning with the safety profile observed in previous studies by Syros.
Following these results, Syros plans to halt the SELECT-MDS-1 trial. The company will conduct a detailed review of the data to determine future actions. This decision comes after the company had previously indicated that not meeting the trial's primary endpoint would constitute a default event under its loan agreement with Oxford Finance LLC.
"We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease," said Conley Chee, CEO of Syros. He expressed gratitude to patients, caregivers, healthcare professionals, and Syros employees for their dedication to the tamibarotene program.
The multinational SELECT-MDS-1 trial was designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of tamibarotene in combination with azacitidine, compared to a placebo with azacitidine, specifically in HR-MDS patients with RARA overexpression.
Syros, known for its commitment to addressing unmet needs in hematologic cancers, will continue to analyze the data from the SELECT-MDS-1 trial and assess its implications. The information presented in this article is based on a press release statement from Syros Pharmaceuticals.
In other recent news, Syros Pharmaceuticals made headlines with its Q3 2024 Earnings Call, where the company provided an update on its progress with tamibarotene, a potential treatment for higher-risk myelodysplastic syndromes (MDS) with RARA gene overexpression. The company's CEO, Conley Chee, highlighted the upcoming pivotal data from the SELECT-MDS-1 Phase 3 trial, expected in mid-November 2024. However, the earnings report revealed no revenue for Q3 2024 and a net loss of $6.4 million. Syros Pharmaceuticals is also preparing for the commercial launch of tamibarotene, focusing on market awareness and infrastructure. The company is exploring business development opportunities for the CDK7 inhibitor asset, 5609. Despite the lack of revenue, Syros Pharmaceuticals maintains sufficient cash to fund operations into Q3 2025. These are recent developments in the company's journey.
InvestingPro Insights
In light of Syros Pharmaceuticals' disappointing Phase 3 trial results, investors may find additional context from InvestingPro's real-time data and tips valuable. The company's market capitalization stands at $74.13 million, reflecting the market's current valuation of the firm following this setback.
An InvestingPro Tip highlights that Syros is "quickly burning through cash," which is particularly relevant given the trial's outcome and the potential need to reassess its research and development strategy. This cash burn rate becomes even more critical as the company faces a potential default event under its loan agreement with Oxford Finance LLC.
Another InvestingPro Tip notes that the stock price movements are "quite volatile," which is unsurprising for a biopharmaceutical company heavily dependent on clinical trial outcomes. This volatility is evident in the recent stock performance, with a significant 67.36% return over the last month, despite a year-to-date price total return of -58.54%.
The company's financial health is further illuminated by its revenue of $0.39 million in the last twelve months as of Q3 2023, with a striking revenue decline of -95.61%. This, coupled with the InvestingPro Tip that "analysts do not anticipate the company will be profitable this year," underscores the challenges Syros faces in commercializing its pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Syros Pharmaceuticals, providing a deeper understanding of the company's financial position and market performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.